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Validation of Patient's Self-Reported Social Functioning As an Independent Prognostic Factor for Survival in Metastatic Colorectal Cancer Patients: Results of an International Study by the Chronotherapy Group of the European Organisation for Research and Treatment of Cancer

Fabio Efficace, Pasquale F. Innominato, Georg Bjarnason, Corneel Coens, Yves Humblet, Salvatore Tumolo, Dominique Genet, Marco Tampellini, Andrew Bottomley, Carlo Garufi, Christian Focan, Sylvie Giacchetti, Francis Lévi

From the European Organisation for Research and Treatment of Cancer Data Center, Quality of Life Unit; Hôpital Universitaire St-Luc, Université Catholique de Louvain, Brussels; Centre Hospitalier Chrétien-Clinique Saint-Joseph, Departement d'Oncologie Medicale, Liege, Belgium; Institut National de la Santé et de la Recherche Médicale, U776, Rythmes Biologiques et Cancers; Assistance Publique-Hôpitaux de Paris, Unité de Chronothérapie, Département de Cancérologie, Hôpital Paul Brousse, Villejuif; Université Paris-Sud, UMR-S0776, Orsay; Centre Hospitalier Universitaire Dupuytren, Oncologie Médicale, Limoges, France; The Toronto-Sunnybrook Regional Cancer Centre, Toronto, Ontario, Canada; Azienda Ospedaliera "Santa Maria degli Angeli", Pordenone; University of Turin, San Luigi Hospital, Regione Gonzole 10, Orbassano; and the Istituto Regina Elena, Department of Medical Oncology, Rome, Italy

Corresponding author: Fabio Efficace, PhD, Italian Group for Adult Hematologic Diseases (GIMEMA), GIMEMA Data Center, Health Outcome Research Unit, Via Benevento, 6, 00161, Rome, Italy; e-mail: f.efficace{at}gimema.it

Purpose A recent study identified a prognostic model for survival in metastatic colorectal cancer patients which included WBC count, alkaline phosphatase (AP), number of metastatic sites, and patients’ self-reported social functioning. The aim of this research is to validate this model on data from an independent sample.

Patients and Methods This validation study is based on a prospective randomized controlled trial in patients with metastatic colorectal cancer conducted by the European Organisation for Research and Treatment of Cancer (EORTC) Chronotherapy Group. Overall, 564 patients in 10 countries were enrolled. For the purpose of this independent validation, patients with health-related quality of life (HRQOL) baseline data were analyzed. HRQOL was assessed using the EORTC Quality of Life Questionnaire C30 (QLQ-C30). The Cox proportional hazards regression model was used for both univariate and multivariate analyses of survival.

Results The previous model with an additional adjustment, by stratification for sex, was replicated and its parameters were confirmed to independently predict survival: WBC count with an hazard ratio (HR) of 1.31 (95% CI, 1.021 to 1.698; P = .034); AP with an HR of 1.53 (95% CI, 1.188 to 1.979; P = .001); number of sites involved with an HR of 1.90 (95% CI, 1.531 to 2.364; P < .0001); and patients’ self-reported social functioning with an HR of 0.94 (95% CI, 0.905 to 0.976; P = .001). The latter translates into a 6% increase in the likelihood of an earlier death for every 10-point decrease in the social functioning scale of the EORTC QLQ-C30.

Conclusion This study provides confirmatory evidence of the independent prognostic value of patients’ self-reported social functioning in patients with advanced colorectal cancer.

Supported in part by the Associazione Italiana per la Ricerca sul Cancro; by Grants No. 2U10 CA11488-31 through 5U10 CA11488-35 from the National Cancer Institute (Bethesda, MD); by the EORTC Charitable Trust; the Chronotherapy Group is now operating under the auspices of the "International Association for Research on Time in Biology and Chronotherapy" (ARTBC International), Paul Brousse Hospital, Villejuif, France. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Presented at the 14th Annual Conference of the International Society for Quality of Life Research, Toronto, Canada, October 10-13, 2007.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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